Zealand drug hit with CRL for ul­tra-rare dis­ease amid man­u­fac­tur­ing con­cerns, plans to re­sub­mit in 2024

The FDA re­ject­ed Zealand Phar­ma’s glucagon re­cep­tor ag­o­nist in con­gen­i­tal hy­per­in­sulin­ism (CHI) af­ter iden­ti­fy­ing prob­lems at a third-par­ty man­u­fac­tur­ing site.

The com­pa­ny said it re­mains …

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